Biosafety - Vironova

Flexible study date – performed by viral clearance testing experts

Vironova Biosafety specialized in viral clearance studies

Vironova Biosafety is a contract research organization (CRO) specialized in viral clearance studies for biological drugs.

We offer viral clearance studies in BSLII and BSLIII certified cell and virus laboratories, in compliance with good laboratory practice (GLP) principles and are GLP certified since 2011. Our services range from early R&D to market release. Literature-based viral risk assessment is also offered by our experts with extensive scientific and regulatory experience.

Our office and laboratories are in central Stockholm. Our customers are found worldwide.

Our offering

Viral clearance testing

Virus validation studies on scaled down versions of selected process steps. Phase I and Phase III.

Viral risk assessment

Review of manufacturing process documentation to assess the risk of potential viral contamination in the final product.

Validation of viral clearance

Examples of process steps studied for viral clearance:

There are two different categories of viral clearance : inactivation and/or removal. Optimizing these viral clearance steps in the manufacturing process to ensure rapid kill and virus reduction is essential. A range of viruses with different physico-chemical properties and virucidal potential are covered within the scope of this validation.

Meeting regulatory requirements

The Vironova Biosafety expert staff can advise on the main guidelines in use; the authorities’ demand for demonstration of viral safety increases as the product moves closer to market release. Vironova Biosafety offers GLP studies in compliance with the latest regulatory guidelines. Upon request customized non-GLP studies are also performed.

virus detection in tissue

This application employs MiniTEM for detection of retroviruses in production cell lines